Product Questionnaire

Please fill out as completely as possible and submit to Kristin Calloway at kristin.calloway@osobio.com using the buttons at the end.

Contact Information

Primary Contact

Product Description

Dosage Form:

Regulatory Status


Timeline & Quanities

Development Batches

Type of Development Batches

Commercial Batches

Estimated commercial sales (in individual units/vials):

Product Safety

Is a Material Safety Data Sheet (MSDS) available?

(If Yes, PLEASE EMAIL TO kristin.calloway@osobio.com)

Merck Based Potency


Product Classification



Is an Industrial Hygiene Method developed?


Cleaning Agents



Process Manufacture

Non-compendial ingredients:

Co-Solvent?


Equipment & Handling

Product or contact Incompatibilities:

Does this process require any specialized equipment?

Are there any handling or special processing requirements?

Foaming

Oxygen Sensitive

Viscous

Shear

Light Sensitive

Sterile Filtration of Final Product

Sterile Compound/Formulation

If product is sterile filtered, has filter validation been performed?

Temperature Requirements:

API Storage:

Compounding:

Filling:

Final Product Storage:

Sterilization & Lyophilization

Is Terminal Sterilization required for the product?

Terminal Sterilization Method

Is Product Lyophilized?

Product Testing

Active Ingredient Incoming Testing

Stability

Will OsoBio be performing stability studies?

Packaging / Inspection Requirements

Special visual inspection characteristics?

Ink jet required

If yes, note location;

Labeling Required?

Note: OsoBio strongly recommends that all finished product vials be labeled or ink-jetted with the lot number.

Packaging Required (If applicable)?

Shipping Validation Required?

If yes, to be provided by:

Component Information

Are you willing to use a site-qualified container closure system (vial, stopper, seal)?

Vial:


Stopper:

Coating:

Aluminum Seal:

Other Pertinent Information

Click SUBMIT to email this questionnaire to the primary contact and Kristin Calloway at OsoBio.